Test bank For Pharmacology For Nurses A Pathophysiologic Approach 5th Edition by Michael Patrick Adams

Test bank For Pharmacology For Nurses A Pathophysiologic Approach 5th Edition by Michael Patrick Adams

Adams, Pharmacology for Nurses: A Pathophysiologic Approach, 5/E
Chapter 2

Question:1

Type: MCSA

The pharmaceutical representative comes to the physician’s office and says his company’s pharmaceutical laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is the best response by the nurse?

1. “Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration (FDA) before marketing a drug.”

2. “Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration (FDA).”

3. “Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from the Food and Drug Administration (FDA).”

4. “Your pharmaceutical laboratory must be involved in academic research because they are exempt from approval by the Food and Drug Administration (FDA).”

Correct Answer: 1

Rationale 1: Any pharmaceutical laboratory must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. 

Rationale 2: Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs.

Rationale 3: Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. 

Rationale 4: Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. 

Global Rationale: Any pharmaceutical laboratory, whether private, public, or academic, must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs.

Cognitive Level: Applying

Client Need: Physiological Integrity

Client Need Sub: Pharmacological and Parenteral Therapies

QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support safety and quality.

AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of health care. 

NLN Competencies: Quality and Safety: Policies and procedures.

Nursing/Integrated Concepts: Nursing Process: Implementation

Learning Outcome: 2-2 Discuss the role of the U.S. Food and Drug Administration (FDA) in the drug approval process.

MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology.

Page Number: 13

Question 2

Type: MCSA

The nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. What is the primary role of the nurse in this phase of the review and approval process by the FDA?

1. To perform tests on the population-at-large

2. To perform tests on various species of animals

3. To perform tests on human cells cultured in the laboratory

4. To perform tests on human clients

Correct Answer: 4

Rationale 1: Performing tests on the population-at-large is the stage of post-marketing surveillance. 

Rationale 2: Performing tests on various species of animals is the preclinical investigation stage.

Rationale 3: Performing tests on human cells cultured in the laboratory is the preclinical investigation stage.

Rationale 4: Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients with a particular disease. 

Global Rationale: Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients with a particular disease. Performing tests on human cells cultured in the laboratory is the preclinical investigation stage. Performing tests on the population-at-large is the stage of post-marketing surveillance. Performing tests on various species of animals is the preclinical investigation stage.

Cognitive Level: Applying

Client Need: Physiological Integrity

Client Need Sub: Pharmacological and Parenteral Therapies

QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support safety and quality.

AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of health care. 

NLN Competencies: Quality and Safety: Policies and procedures.

Nursing/Integrated Concepts: Nursing Process: Implementation

Learning Outcome: 2-5 Identify the nurse’s role in the drug approval process and in maintaining safety practices.

MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology.